View clinical trials related to Crohn Disease.
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People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, people with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the researchers want to understand the treatment of sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. This study will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat insomnia symptoms. CBT-I is the recommended treatment for insomnia and has been shown to improve sleep problems, pain, and inflammation in other groups of people. If this study is successful, it will contribute to understanding how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.
Objectives: Primary Objectives Substudy A - Phase 2 - To evaluate the safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn's disease (CD) Substudy 1 - Phase 2b - To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active CD - To select an oral etrasimod dose(s), based on efficacy and safety, for continued development Substudy 2 - Induction (Phase 3) - To evaluate the efficacy of the selected etrasimod dose versus placebo as induction therapy in subjects with moderately to severely active CD Substudy 3 - Maintenance (Phase 3) - To evaluate the efficacy of etrasimod versus placebo as maintenance therapy in subjects with moderately to severely active CD Substudy 4 - Long-Term Extension - To evaluate the long-term safety and tolerability of etrasimod in subjects with moderately to severely active CD Secondary Objectives Substudy A - Phase 2 - To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active CD - To evaluate the pharmacokinetic (PK) and pharmacodynamic effects of etrasimod as induction and maintenance therapy, including changes in lymphocytes, C-reactive protein (CRP), and fecal calprotectin (FCP) in subjects with moderately to severely active CDSubstudy 1 - Phase 2b - To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active CD - To provide a subset of the target study population, etrasimod responders, to be evaluated in Substudy 3 - Maintenance Substudy 2 - Induction (Phase 3) - To evaluate the safety and tolerability of the selected etrasimod Phase 3 dose (3 mg or 2 mg) versus placebo as induction therapy in subjects with moderately to severely active CD - To provide a subset of the target study population, etrasimod responders, to be evaluated in Substudy 3 - Maintenance Substudy 3 - Maintenance (Phase 3) - To evaluate the efficacy of etrasimod on sustained clinical remission and endoscopic response, endoscopic remission, and corticosteroid-free clinical remission in subjects with moderately to severely active CD - To characterize the safety and tolerability of etrasimod as maintenance therapy in subjects with moderately to severely active CD Substudy 4 - Long-Term Extension - To evaluate the long-term efficacy of etrasimod in subjects with moderately to severely active CD
The purpose of this study is to evaluate the clinical and endoscopic efficacy and safety of ustekinumab in Chinese participants with moderately to severely active Crohn's disease.
The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD).
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Participants get standard treatment for Crohn's disease and the strictures. The purpose of the study is to test whether the strictures improve further when treated with a medicine called spesolimab added to standard treatment. Participants are in the study for about 1 year and 4 months. In the first 3 months, participants get standard treatment only. After 3 months, participants whose condition improved are put into 2 groups randomly, which means by chance. One group gets spesolimab added to their standard treatment. The other group gets placebo added to their standard treatment. Both spesolimab and placebo are given as infusions into a vein. Placebo infusions look like spesolimab infusions but do not contain any medicine. For the first 2 months, participants get the infusions every month. Thereafter, participants get the infusions every 2 months. During the study, participants have about 11 visits to the study site. The doctors regularly check participants' health and take note of any unwanted effects. At 3 of the visits, doctors take images of the bowel using Magnetic Resonance Imaging and with an endoscope. At these visits, the doctors also take a small sample of bowel tissue (biopsy). The participants note their symptoms of Crohn's disease and how the symptoms affect daily life in an electronic diary. At the end of the study, results from the diaries and bowel imaging are compared between the spesolimab group and the placebo group.
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection. Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The European Crohn's and Colitis Organisation (ECCO) guideline recommended that endoscopic balloon dilatation is suitable to treat short [<5 cm] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation. However, there is no prospective clinical studies evaluating the efficacy and safety of endoscopic stricturotomy in the treatment of fibrostenotic Crohn's disease. The trial aims to compare the efficacy and safety of endoscopic stricturotomy with endoscopic balloon dilation in the treatment of small bowel stricture in patients with Crohn's Disease.
The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.
Crohn's disease (CD) is a chronic inflammatory bowel disease. CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts. The purpose of this study is to evaluate de clinical efficacy of the fecal microbiota transplantation (FMT) as a maintenance treatment following anti-TNF agent withdrawal in CD's patient.